QC Tech II

Job Description

The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed.

• Performs in process testing for internal customers.
• Performs finished goods, returned goods, and stability testing for external customers as needed.
• Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
• Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed.
• Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system.
• Troubleshoots and performs routine maintenance on laboratory instrumentation.
• Prepares all standards and reagents needed for proper execution of analytical methods and procedures.

Department Specific/Non-essential Functions

• Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment.
• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
• Aids in solving plant problems.
• Works on solving problems and implementing improvements in a teaming environment.
• Uses problem solving skills to help with failure investigations and testing problems.
• Communicates any uncompleted work to the next shift, as well as any immediate priorities.
• Reports to Quality Testing and Release Manager.
• Frequent interact with operators, engineers, and Quality management for reporting routine analytical results.

Education

• Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred.
• Appropriate experience may be a suitable replacement for degree.

Experience

• 1 – 3 years laboratory experience in a pharmaceutical manufacturing operation preferred.
• Working knowledge of cGMP is a plus.

Skills/Qualifications

• Must be able to perform basic mathematical calculations.
• Familiarity with basic laboratory procedures, equipment, and computer key punching.
• Sound and correct technical judgments are required during routine analysis.
• A high degree of concentration is required.
• Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test).
• If testing criteria are not met with uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them.
• Functional/Technical Skills, Priority Setting, Written Communication.
• Customer Focus, Organizing Relationship With Others/ Scope.

Communication

• Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities.
• Majority of work is performed independently without direct supervision.
• Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel.
• Reports to Quality Testing and Release Manager.
• Frequent interact with operators, engineers, and Quality management for reporting routine analytical results.
• Communication may be though radio, telephone, email, or in person.
• Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers.

Working Conditions

• Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments.
• Packages of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area.
• Exposure to fugitive emissions of chemicals typical for chemical operations.
• Normal dexterity is required for routine handling of laboratory glassware and instruments.
• Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished.
• Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position.
• Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed.